1. Field of the Invention
This invention relates to and has among its objects provision of novel immunizing agents. Further objects of the invention will be evident from the following description wherein parts and percentages are by weight unless otherwise specified.
2. Description of the Prior Art
The importance of the humoral defense system, immune globulin (IG) has long been recognized. IG preparations for therapeutic use have been available for about 30 years, however, the structure and function of IG ("gamma globulins") has only been understood in detail for a few years. Five classes of immunoglobulins are now recognized: IgA, IgG, IgM, IgE and IgD. The functions of the first four classes have been extensively researched, whereas the clinical significance of IgD is still essentially unknown. The bulk of the serum immunoglobulins (approximately 70%) are IgG, and they are the carriers of many of the body's acquired defensive functions. Like the other forms of IG, the IgG molecule consists of heavy and light polypeptide chains. Proteolytic enzymes can be used to split IgG into various fragments, called Fc, Fd and Fab fragments. For the immunoglobulin molecule to be fully functional and hence therapeutically effective, it is believed that its molecular integrity, particularly its primary or tertiary molecular structure, must be retained or, if not, its function would be impaired.
Intramuscularly injectable (IM) and intravenously injectable (IV) immune globulin preparations for parenteral administration are known. The IVIG material contains either a modified or unmodified IG molecule or both.
It has been observed that breast-fed newborn infants are better protected against gastrointestinal infection than are formula-fed infants. (Jelliffe, Amer. J. Clin. Nutr., 29, 1227, 1976; Kleinman et al., Digestive Diseases and S.C., 24 (11):876:82, 1979; Beer et al., J. Invest. Dermat., 63:55-74, 1974; Ammann et al., Soc. for Exp. Biol. and Med., 122:1098-1101, 1966; Lourguia et al., Arch. Argent. Pediat., 72:109-125, 1974; Hilper et al., "Food and Immunology", Hambraeus L., Hanson L. A., McFarlane H. (Eds) pp. 182-196, 1977; Hanebery et al., Eur. J. Pediatr., 132:239, 1979). This can be accounted for by the presence of T and B lymphocytes, phagocytes, antibodies, complement components and other anti-bacterial substances such as lactoferrin and lysozyme. The relative importance of these elements in milk is difficult to assess although removal of cells by heating or centrifugation may lead to a significant loss in protective ability (Pitt et al., Ped. Res., 11, 906, 1977).
U.S. Pat. No. 4,096,244 describes a dried particulate porcine or bovine blood serum containing immunoglobulins which is acceptable to and palatable to newborn piglets when orally administered to piglets as a feed stuff component.
In U.S. Pat. No. 3,975,517 a method is described wherein cows are vaccinated with a particular vaccine for coliform enteritis. Recovered milk from the so-vaccinated cows can be orally fed to newborn calves on a continuous basis.
An immune milk product containing antibodies is disclosed in U.S. Pat. No. 3,911,108 and may be administered to baby pigs to protect against transmissible gastroenteritis.
Milk obtained from milk-bearing animals which have been treated with a specific mixed bacterin vaccine is described in U.S. Pat. No. 3,128,230. The milk may be administered to human and lower animals for treatment of various diseases.
In U.S. Pat. No. 2,607,716 there is disclosed a composition for preventing or inhibiting scours in calves, lambs, goats, pigs, rabbits, and the like. Plasma, serum, or globulin fraction of pooled blood from dairy cattle, sheep, or pigs containing immune proteins is spray-on freeze-dried and mixed with a solid Vitamin K source and partially digested milk solids. In use the mixture is mixed with water and orally administered to the animal to be treated.